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Quidel Corporation Receives FDA Clearance for New Strep A Test
SAN DIEGO, May 17 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL), a leading provider of point-of-care (POC) rapid diagnostic tests, today announced the clearance by the U.S. Food and Drug Administration (FDA) of the Company's QuickVue(R) Dipstick Strep A test.
This new test is Quidel's first dipstick-style Strep A test and adds to the Company's existing portfolio of Strep A tests, which includes QuickVue(R) In-Line(R) Strep A test, QuickVue(R) Flex Strep A test, and the CARDS(R) O.S.(R) Strep A test.
"Our QuickVue(R) Dipstick Strep A test was developed based upon strong demand from our customers and represents an important extension of Quidel's rapid Strep A testing portfolio. Clearance from the FDA allows us to offer a comprehensive line of rapid diagnostic strep tests," said S. Wayne Kay, Quidel's President and Chief Operating Officer.
"We are the leader in rapid POC Group A strep testing in the United States and with our dipstick product, we expect to solidify that leadership position. Moreover, developing new medical products of the highest quality is a key element of our commitment to innovation and industry leadership."
Group A streptococcus is responsible for common infections of the throat collectively known as "Strep throat". Left untreated these infections can lead to life-threatening diseases including rheumatic fever and pneumonia. In the U.S. alone, it is estimated that there are 25-35 million physician visits each year for suspected Group A streptococcal infections, making it one of the most common childhood illnesses for which no preventive vaccine exists.
About Quidel Corporation
Quidel Corporation discovers, develops, manufactures and markets point-of-care, rapid diagnostic tests for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions that affect women's health throughout the phases of their lives including reproductive status, pregnancy management and osteoporosis. Quidel also provides point-of-care diagnostics for infectious diseases, including influenza A and B, strep throat, H. pylori infection, chlamydia, infectious mononucleosis, and bacterial vaginosis. Quidel's products are sold to healthcare professionals for use in physicians' offices, clinical laboratories and pharmacies, and to consumers through organizations that provide private label, store brand products. These tests provide diagnostic information to enable rapid treatment and improve health outcomes, lower costs, and increase patient satisfaction. For more information, please visit Quidel's Web site at http://www.quidel.com.
This press release contains forward-looking statements regarding Quidel's future activities within the meaning of the federal securities laws. These forward-looking statements involve material risks and uncertainties. Many possible factors could affect the future results and performance of Quidel's products, such that actual results and performance may differ materially. If Quidel's products fail to perform as expected, or if there is lower consumer demand for these products than expected, Quidel's financial condition and operating results may be materially and adversely affected. Quidel's financial condition and operating results may also be materially and adversely affected by a number of other factors, including, without limitation, seasonality, adverse changes (both domestically and internationally) in competitive and economic conditions, actions by the Company's distributors, manufacturing and production delays or difficulties and adverse actions or delays in product reviews by the FDA. Please see the discussion of these and other factors in Quidel's annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.
Bruce Voss, firstname.lastname@example.org,
or Martin Halsall, email@example.com,
both of Lippert/Heilshorn & Associates,310-691-7100, for Quidel Corporation;
or Sharon Platt, Investor Relations Associate, 858-552-7955,
or Charles J. Cashion, Chief Financial Officer, 858-552-7962,
both of Quidel Corporation